| There are about 30% adults who suffer from AL are difficult to initial treatment. After receiving CR, 60% of the patients will recur and become difficult to treat ultimately, even after transplantation of haemopoietic stem cell. Bad reaction to treatment, low induced relieving rate, high recurrence rate, and short survival period are tough problem in the treatment of refractory acute leukemia (RAL). So combined chemotherapy is still the main treatment method. MDR is the main reason which causes its refractoriness. Studying the mechanism of the cause and resolving method of MDR is one of the main means of enhancing the curative effect of leukemia. It has been proved that many compounds, biological preparations and Chinese herbs have the effect of reversing MDR of tumor or leukemia cells. However, the apply of these preparations are greatly limited due to its great side effect and bad clinical curative effect, not to say the study is still at the stage of out-of-body.Previous study on MDR in our department shows that the alkaloid of Fritillary Bulb has the biological activity of reversing MDR of leukemia cells. It can also enhance the anti-tumor drug concentration in AL cells. Clinical preliminary experiment shows that the totally relieving rate of treatment group is significantly higher than that of control group. Its ascendancy is more significant for refractory and recurrent leukemia patients. It can also enhance the curative effect on patients with high Pgp expression. On this base, we run a prospective, double-blind-method, and multi-center clinical study first time to interfere in RAL ambi-chemotherapy mainly treated with Chinese herbs in domestic. We strictly observe the randomized allocation and double blind method principle in clinical study, institute coincident clinical research program and CRF, divide treat group and control group according to random arrangement created by computer. In addition to applying standard chemotherapy, drug granules is prescribed 3 days before chemotherapy. Ten grams of Fritillary Bulb and malt, three times a day, were given to the treatment group and control group respectively. Any other drugs which can reverse MRD in leukemia were ruled out. All the patients had their drugs 14 days continuously, with the standard chemotherapy period being a treatment cycle. If it was ineffective after a course of treatment, the patient could continue to have these drug granules and be observed for another course of treatment as another man-time. The research staff must attend a certain training so that they will know well the clinical research plan, and strictly note down every index (including primitive granulocyte counts in both marrow and peripheral blood, peripheral blood counts, MDR relative protein, safety index, etc.) and untoward affairs before and after chemotherapy. They should also judge the clinical curative effect. In the end, the result will be uncovered by two steps before statistical analysis.All the cases are from 12 hospitals through the country, and were all in-patients between January, 2004 and April, 2006. There were 66 cases in treatment group and 61cases in control... |
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